JP4965459B2 - Intervertebral prosthesis - Google Patents

Intervertebral prosthesis Download PDF

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Publication number
JP4965459B2
JP4965459B2 JP2007548661A JP2007548661A JP4965459B2 JP 4965459 B2 JP4965459 B2 JP 4965459B2 JP 2007548661 A JP2007548661 A JP 2007548661A JP 2007548661 A JP2007548661 A JP 2007548661A JP 4965459 B2 JP4965459 B2 JP 4965459B2
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JP
Japan
Prior art keywords
intervertebral prosthesis
prosthetic
intervertebral
cap
prosthesis
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP2007548661A
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Japanese (ja)
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JP2008525128A (en
Inventor
レヒマン,ビート
フライグ,ローベルト
アッペンツェラー,アンドレアス
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Synthes GmbH
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Synthes GmbH
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Application filed by Synthes GmbH filed Critical Synthes GmbH
Publication of JP2008525128A publication Critical patent/JP2008525128A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442Intervertebral or spinal discs, e.g. resilient
    • A61F2/4425Intervertebral or spinal discs, e.g. resilient made of articulated components
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30092Properties of materials and coating materials using shape memory or superelastic materials, e.g. nitinol
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30601Special structural features of bone or joint prostheses not otherwise provided for telescopic
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616Sets comprising a plurality of prosthetic parts of different sizes or orientations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30621Features concerning the anatomical functioning or articulation of the prosthetic joint
    • A61F2002/30649Ball-and-socket joints
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/443Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
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    • A61F2002/4625Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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    • A61F2310/00574Coating or prosthesis-covering structure made of carbon, e.g. of pyrocarbon
    • A61F2310/0058Coating made of diamond or of diamond-like carbon DLC
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    • A61F2310/00592Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/0073Coating or prosthesis-covering structure made of compounds based on metal carbides
    • A61F2310/00748Coating made of titanium carbide

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Neurology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Public Health (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Automatic Disk Changers (AREA)
  • Holders For Sensitive Materials And Originals (AREA)
  • Belt Conveyors (AREA)
  • Portable Nailing Machines And Staplers (AREA)

Abstract

The prosthetic joint has at least two members having each a cooperating articulating surface layer on a substrate material. At least one of said articulating surface layers comprises amorphous diamond-like carbon; or Titanium Nitrate (TiN) on a bonding layer bonded to the substrate material. The prosthetic joint provides a reduction of the number of wear debris and shows enhanced dry run properties.

Description

発明の詳細な説明Detailed Description of the Invention

本発明は椎間補綴に関連し、特に椎間板補綴に関する。   The present invention relates to an intervertebral prosthesis, and more particularly to an intervertebral disc prosthesis.

近年、椎間補綴は脊椎の外科処置において広く受け入れられてきている。これらの補綴は、椎間板内で脊椎の前方または前後間に挿入される。この植え込み技術はあるリスクを表示し、アクセスは腹部領域を通過して導く。前面腰部段の領域のより大きな管が傷付くリスクが存在する。バイオメカニカルの観点から前方のアクセスは不利であり、補綴の挿入を可能にするために、脊椎の前方の縦の靭帯は部分的にまたは全体的に解剖される。解剖は脊椎体のある不安定さの要因となり、最悪の場合,腹部の補綴の移動を促進する。補綴移動のリスクを低減させるために、近接する脊椎の被覆板上に補綴を固定する様様な固着手段が使用される。   In recent years, intervertebral prostheses have gained wide acceptance in spinal surgery. These prostheses are inserted in the intervertebral disc anteriorly or anteroposteriorly of the spine. This implantation technique displays a certain risk and access is directed through the abdominal region. There is a risk that the larger tube in the area of the front waist step will be damaged. Anterior access is disadvantageous from a biomechanical point of view, and the longitudinal ligaments in front of the spine are partially or wholly dissected to allow prosthetic insertion. Anatomy causes some instability of the vertebral body and, in the worst case, promotes the movement of the abdominal prosthesis. In order to reduce the risk of prosthetic movement, anchoring means are used, such as fixing the prosthesis on the adjacent spinal cover plate.

この型の椎間板補綴はマルナイ等の国際公開第01/01893号パンフレットとして知られている。この既知の補綴はボールソケット結合を有し、2つの脊椎で補綴に固着する2つの異なる型の投影とを含む。前記書面において補綴の高さを最小化することが提案されており、2つの部品は互いに係合するよう構成されておりその内部に挿入される。固着手段が提供されたにもかかわらず、挿入チャネルに沿って移動のための補綴リスクが存在する。   This type of intervertebral disc prosthesis is known as WO 01/01893, such as Marnai. This known prosthesis has a ball socket connection and includes two different types of projections that are secured to the prosthesis at two vertebrae. It has been proposed to minimize the height of the prosthesis in the document, and the two parts are configured to engage each other and are inserted therein. Despite the provision of anchoring means, there is a prosthetic risk for movement along the insertion channel.

本発明は、このための治療法を提供することを意図している。本発明は椎間補綴へ導いており、植え込みの目的は分解可能な2つの部分であり、経椎間孔および/または椎間穴外のアクセス経由で椎間空間に挿入される。椎間補綴の関節は好適には球状の帽子状構造と対応する球状の凹部から構成される。2つの補綴要素の植え込みでは、2つの分けられたアクセス経由で椎間空間で分けて植え込みされ、椎間空間内で他に互いに補綴要素の縦軸が配置される。2つの補綴要素の縦軸の間に角度αが自由に選択されることで、交差する点の位置は、変化せず維持されている挿入点とともに矢印方向に調整しうる。この調整は手術前にCTまたはX線写真手段によって計画することができ、ガイドワイヤおよび/または鋳型の手段によって手術中に定義することもできる。   The present invention is intended to provide a treatment for this. The present invention leads to an intervertebral prosthesis, the purpose of implantation being two parts that can be disassembled and inserted into the intervertebral space via transvertebral foramen and / or access outside the intervertebral foramen. The joint of the intervertebral prosthesis is preferably composed of a spherical cap-like structure and a corresponding spherical recess. In the implantation of two prosthetic elements, it is implanted separately in the intervertebral space via two separate accesses, and the longitudinal axis of the prosthetic element is arranged in the other intervertebral space. By freely selecting the angle α between the longitudinal axes of the two prosthetic elements, the position of the intersecting point can be adjusted in the direction of the arrow with the insertion point being maintained unchanged. This adjustment can be planned by CT or radiographic means prior to surgery and can also be defined during surgery by means of a guide wire and / or mold.

本発明によって達成される利点は、本質的に本発明の椎間補綴に起因する事実内に存在する。
− いかなる組合せの脊柱の椎間補綴の個々の調整も可能である。動作素子の個々の組織は配慮されうる。
− 個々のセグメントの動作配列は手術前に配慮され、外科医によって特徴付けられる。
− 複雑でなく安全な手術技術は、完全な状態に組み立てられた椎間空間内に挿入される植え込みへ比較されて可能にされる。
− 脊柱の湾曲/拡張または側方への屈曲に起因して前方と後方および/または側方への補綴の移動によるリスクは最小化される。
− 自然な椎間板が部分的にのみ除去されねばならず、すなわち、椎間空間(椎間板)内の2つの補綴要素を植え込むために、幅Bと長さHの2つの方針を明らかにすることのみが必要であり、2つの補綴要素の同格の表面のみが各端板と骨内で接触する。一度2つの補綴要素が植え込まれると、椎間板の残りはそのままの状態で維持され、椎間補綴が側面および/または前方および後方に移動するのを妨げる。
The advantages achieved by the present invention reside within the facts inherently resulting from the intervertebral prosthesis of the present invention.
-Individual adjustments of any combination of spinal intervertebral prostheses are possible. The individual organization of the operating elements can be taken into account.
-The motion sequence of the individual segments is considered before surgery and is characterized by the surgeon.
-Complex and safe surgical techniques are enabled in comparison to implants inserted into fully assembled intervertebral spaces.
-Risk due to movement of the prosthesis forward and backward and / or laterally due to spinal curvature / dilation or lateral flexion is minimized.
-The natural disc must only be partially removed, ie only to reveal two strategies of width B and length H in order to implant two prosthetic elements in the intervertebral space (disc) Only the equivalent surfaces of the two prosthetic elements are in contact with each endplate in the bone. Once the two prosthetic elements are implanted, the remainder of the disc is maintained intact, preventing the intervertebral prosthesis from moving laterally and / or anteriorly and posteriorly.

好適な実施例では、補綴要素の高さHと同幅Bとの比が3対1から5対1の間である。この設計の効果は本質的に椎間空間(椎間板)内で2つの補綴要素を植え込むために、幅Bと長さHの狭い道筋を明らかにすることのみが必要である。   In a preferred embodiment, the ratio of height H to width B of the prosthetic element is between 3: 1 and 5: 1. The effect of this design is essentially only to reveal a narrow path of width B and length H in order to implant the two prosthetic elements within the intervertebral space (disc).

他の実施例では、椎間補綴は2つの部品から構成され、すなわち帽子状構造は2つの補綴要素のうちの1つと他の1つの部品から構成される。   In another embodiment, the intervertebral prosthesis is composed of two parts, ie the cap-like structure is composed of one of the two prosthetic elements and the other part.

更なる実施例において、椎間補綴は3つの部品から構成され、3つの部品から形成される帽子状構造は2つの補綴要素うちの1つと接続可能である。この設計の効果は、板と帽子状構造は異なる物質を使用することによって構成され、関節表面のために最適な摺動特性を達成することが可能となるという事実に本質的に見られる。板のための好適な物質は、チタニウムまたはチタニウム合金またはPEEKまたはコートされた変異型であり、帽子状構造にとっては高度に架橋されたポリエチレン(X−UHMWPE)コバルトとクロムの合金又はセラミック物質である。   In a further embodiment, the intervertebral prosthesis is composed of three parts, and a cap-like structure formed from the three parts is connectable with one of the two prosthetic elements. The effect of this design is essentially seen in the fact that the plate and the cap-like structure are constructed by using different materials, making it possible to achieve optimal sliding properties for the joint surface. Suitable materials for the plates are titanium or titanium alloys or PEEK or coated variants, and for hat-like structures are highly crosslinked polyethylene (X-UHMWPE) cobalt and chromium alloys or ceramic materials. .

再び更なる実施例では、椎間補綴は、少なくとも3つの部品から構成されて関節殻を含み、この殻は第三の部分として第一および第二の補綴要素に脱着可能な凹部を含む。この設計の効果は、板と帽子状構造は異なる物質を使用することによって構成され、関節表面のために最適な摺動特性を達成することが可能となるという事実に本質的に見られる。   In yet a further embodiment, the intervertebral prosthesis is constructed of at least three parts and includes an articulating shell that includes a recess that is detachable from the first and second prosthetic elements as a third portion. The effect of this design is essentially seen in the fact that the plate and the cap-like structure are constructed by using different materials, making it possible to achieve optimal sliding properties for the joint surface.

更なる実施例では、帽子状構造と関節殻は金属とプラスティックの組み合わさった物質から構成される。この設計の効果は、結合、再配置物質の実績のある組合せを使用することが可能であり、例えば、高度に架橋されたポリエチレン(X−UHMWPE)およびコバルトとクロムの合金である。さらなる効果は、低摩擦力が関節表面の関連する移動のために達成可能であり、軸効果の負荷補償が達成可能であるという事実に見られる。   In a further embodiment, the cap-like structure and the joint shell are composed of a combination of metal and plastic. The effect of this design is that it is possible to use proven combinations of bonding and rearrangement materials, such as highly crosslinked polyethylene (X-UHMWPE) and cobalt and chromium alloys. A further effect is seen in the fact that low friction forces can be achieved due to the associated movement of the joint surface and load compensation of the axial effect can be achieved.

また他の実施例ではセラミックトゥセラミックの関節に使用される。   In another embodiment, it is used for ceramic-to-ceramic joints.

更なる表面の実施例において、帽子状構造と凹部の表面は炭化チタンまたはアモルファス炭素(ADLC)によって被覆されており、摩擦率を実質的に削減している。   In a further surface embodiment, the cap-like structure and the surface of the recess are coated with titanium carbide or amorphous carbon (ADLC), substantially reducing the coefficient of friction.

他の実施例では、少なくとも帽子状構造が膨張能力を有する物質からなる(例えばハイドロゲル)。   In another embodiment, at least the cap-like structure is made of a material having an expansion capability (eg, hydrogel).

また、他の実施例として、帽子状構造は、モノマー、コモノマー、ホモポリマー、オリゴマー、または、流動性および熱硬化性を有する物質を含む混成物質からなり、熱硬化性および流動性物質は以下のグループ
a)ポリエチレングリコール、好適にはポリエチレングリコール(ジ)−アクリレート
b)n−ビニルピロリドン
c)ビニル、好適にはビニルアルコール
d)スチレン
から選択される。
As another example, the cap-shaped structure is composed of a monomer, a comonomer, a homopolymer, an oligomer, or a hybrid material including a material having fluidity and thermosetting property. Groups a) polyethylene glycol, preferably polyethylene glycol (di) -acrylate b) n-vinyl pyrrolidone c) vinyl, preferably vinyl alcohol d) styrene.

得られたポリマーは、それらの弾力性に応じて広く変化しうる。この設計の効果は、結合部の削減された体積に起因し、椎間補綴の挿入がより侵襲的でなくなり、増大する体積が最適な関節機能の達成のためにもっとも適しているという事実に本質的に見られる。   The resulting polymers can vary widely depending on their elasticity. The effect of this design is due to the reduced volume of the joint, essentially due to the fact that the insertion of the intervertebral prosthesis is less invasive and the increased volume is most suitable for achieving optimal joint function Can be seen.

さらなる実施例として、第一の補綴要素は、少なくともM≧2である第一の補綴要素の第一のキットから選択され、第二の補綴要素は、少なくともN≧2である第二の補綴要素の第二のキットから選択される。前記第一と第二のキットは、異なる高さと、関節の橈骨又はそれぞれの橈骨の中心に位置する、すなわち、回転中心である。以下の効果この実施例の手段によって達成されている。この実施例によって以下の効果が達成される。
− 回転中心の位置は、2つの要素部モジュラーの方法で配置される際に高さを調整可能である。
− 要素は、帽子状構造の半径変化させることができ、椎間補綴の回転中心の調整が可能である。
− 回転中心の位置と角度測定と、椎間補綴の並進運動の部分が相対的に広い範囲で自由に選択され、補綴要素の並進運動部は互いに補綴要素の中央軸へ横方向に計測される移動部である。
− 補綴要素は移動部分の関節の要求に配慮し、異なる半径を有する帽子状構造を含めることを可能にする。より大きい帽子状構造の半径は並進運動のより高度な部分の偏差の範囲内であり、患者の脊柱の屈曲が小関節の結合上への圧力を増大させ、変性を加速させる。
− 補綴要素の高さと椎間補綴の関節用帽子状構造の対応する半径は変形でき、様々な椎間空間の規模に適合性がある。
As a further example, the first prosthetic element is selected from a first kit of first prosthetic elements with at least M ≧ 2, and the second prosthetic element has at least N ≧ 2 Selected from the second kit. The first and second kits are located at different heights and at the centers of the joint ribs or the respective ribs, ie the center of rotation. The following effects are achieved by the means of this embodiment. The following effects are achieved by this embodiment.
-The position of the center of rotation can be adjusted in height when it is arranged in a modular manner with two elements.
-The element can change the radius of the cap-like structure, and the center of rotation of the intervertebral prosthesis can be adjusted.
-The position and angle measurement of the center of rotation and the translational part of the intervertebral prosthesis are freely selected in a relatively wide range, and the translational parts of the prosthetic elements are measured laterally to each other on the central axis of the prosthetic element It is a moving part.
The prosthetic element takes into account the joint requirements of the moving part and makes it possible to include cap-like structures with different radii; The radius of the larger cap-like structure is within the deviation of the higher part of the translational movement, and the patient's spinal flexion increases the pressure on the joint joint and accelerates degeneration.
The height of the prosthetic element and the corresponding radius of the joint cap structure of the intervertebral prosthesis can be deformed and are compatible with the size of the various intervertebral spaces.

椎間板補綴は、椎間空間内に椎間補綴を植え込みする方法において、
A)椎間補綴の中央軸に椎間領域の横に第一のアクセスを経由して第一の補綴要素を植え込む植込み工程と、
B)椎間補綴の中央軸へ椎間領域の横で、第一のアクセスとは異なる第二のアクセスを経由して椎間補綴の第二の補綴要素を植え込み、幅の値がBであり高さの値がHであり、H>Bである中央軸について横方向で2つの補綴要素について計測し、第一および第二の補綴要素の縦軸LおよびLが互いに角度α>0度で長さHと交差する平行線を延長する工程と、
C)第二の補綴要素と第一の補綴要素が埋め込みの期間中に明確な方法で結合する工程とからなる。
An intervertebral disc prosthesis is a method of implanting an intervertebral prosthesis in an intervertebral space,
A) implanting a first prosthetic element via a first access on the central axis of the intervertebral prosthesis next to the intervertebral region;
B) Implanting the second prosthetic element of the intervertebral prosthesis via a second access different from the first access to the central axis of the intervertebral prosthesis and having a width value of B Measured for two prosthetic elements in the transverse direction with respect to the central axis where the height value is H and H> B, the longitudinal axes L 1 and L 2 of the first and second prosthetic elements are at an angle α> 0 Extending a parallel line intersecting the length H in degrees;
C) The second prosthetic element and the first prosthetic element are combined in a well-defined manner during implantation.

本発明の方法の実施例の型によれば、少なくとも1つのアクセスが経椎間孔または椎間孔外に配置される。経椎間孔アクセスは、脊柱の外科療法として既知であり確立されている。椎間孔外アクセスのために、逆に腹部または背部の靭帯または神経構造に作用することなく椎間板空間に向けて大きな開口を有することは可能である。   According to a type of embodiment of the method of the present invention, at least one access is placed outside the transvertebral foramen or extravertebral foramen. Transforaminal access is known and established as spinal surgery. For extravertebral access, it is possible to have a large opening toward the disc space without adversely affecting the abdominal or dorsal ligaments or nerve structures.

好適な実施例として、2つのアクセスは補綴に配置される。   As a preferred embodiment, the two accesses are located on the prosthesis.

他の実施例として、第一のアクセスは経椎間孔に配置される。   As another example, the first access is placed in the transvertebral foramen.

さらに他の実施例では第二のアクセスは椎間孔外に配置される。   In still other embodiments, the second access is located outside the intervertebral foramen.

加えて他の実施例では、2つの脊椎体の間の空間内に位置する椎間板は、骨上で隣接して設計される2つの補綴要素の全部同格の表面が脊椎体の各端板と接触する程度に除去される。   In addition, in another embodiment, the intervertebral disc located in the space between the two vertebral bodies is such that the all-equal surfaces of the two prosthetic elements designed adjacent on the bone contact each endplate of the vertebral body It is removed to the extent that you do.

またさらなる実施例では、2つのアクセスはそれぞれ1つの入力点Eを有していて前記点Eは矢印軸10から間隔を空けて2つの植え込まれた補綴要素の縦軸LおよびLが角度αを形成するように前後方向に中央に拡張するように配置され、角度αの設定範囲が25度から120度である。 In a still further embodiment, each of the two accesses has an input point E, which is spaced from the arrow axis 10 by two implanted prosthetic element longitudinal axes L 1 and L 2. It arrange | positions so that it may expand in the center in the front-back direction so that angle (alpha) may be formed, and the setting range of angle (alpha) is 25 degree | times to 120 degree | times.

以下のように、本発明の発明と改善は、本発明に従って、椎間補綴の実施例の部分的な図表を参照して、極めて詳細に図示される。   In the following, the invention and improvements of the present invention are illustrated in greater detail with reference to a partial diagram of an embodiment of an intervertebral prosthesis according to the present invention.

図1に示される実施例は、本質的に椎間補綴1を含み、この椎間補綴1は長方形の同格表面4,5を有する2つの補綴要素2,3から構成される。前記2つの補綴要素2,3は、高さがH,幅がBであるが、関節14の手段により互いに解放可能に接続される。この関節14は、帽子状部9と対応する凹部11から構成される。この実施例では、帽子状部9の半径は補綴要素3の幅Bよりも大きいが、前記補綴要素3の高さHより低く、高さHは幅Bよりもその4,5倍以上長い。この設計の特徴により、互いに関連して、角度αの大きさに依存して、2つの補綴要素2,3の縦軸L,Lの傾斜が全体として異なるようになる(ここでαは中央軸6と垂直に広がる平面内で縦軸L、L軸間の角度αである)。最適な関節の機能は、90度における角度αで達成される。前記角度が90度である場合には、傾斜角は0度における角度αでの大きさの2倍となる。 The embodiment shown in FIG. 1 essentially comprises an intervertebral prosthesis 1, which is composed of two prosthetic elements 2, 3 having rectangular equal surfaces 4, 5. The two prosthetic elements 2 and 3 have a height H and a width B, but are releasably connected to each other by means of a joint 14. The joint 14 is composed of a cap-shaped portion 9 and a concave portion 11 corresponding to the cap-shaped portion 9. In this embodiment, the radius of the cap-shaped portion 9 is larger than the width B of the prosthetic element 3, but is lower than the height H of the prosthetic element 3, and the height H is four or five times longer than the width B. Due to this design feature, the slopes of the longitudinal axes L 1 , L 2 of the two prosthetic elements 2, 3 as a whole differ in relation to each other, depending on the magnitude of the angle α (where α is The angle α between the longitudinal axes L 1 and L 2 in a plane extending perpendicular to the central axis 6). Optimal joint function is achieved with an angle α at 90 degrees. When the angle is 90 degrees, the inclination angle is twice the size at the angle α at 0 degrees.

図2に示される実施例は、第一および第二の補綴要素2,3を含み、この第一および第二の補綴要素2,3は縦軸LとLと矢印軸10を有する手段である。2つの補綴要素2,3の縦軸L;Lは交点Sを有し、角度αを形成する。入り口の点Eと、この点Eは矢印軸10を対象に配置され、椎間内の2つの補綴要素2;3の間に挿入される点の印をつけ、この点Eと断面S点との間の距離は、補綴軸LおよびL(図3,4)により形成される異なる角度αに変化する。 The embodiment shown in FIG. 2 includes first and second prosthetic elements 2, 3, which first and second prosthetic elements 2, 3 have longitudinal axes L 1 , L 2 and an arrow axis 10. It is. The vertical axis of the two prosthetic elements 2,3 L 1; L 2 has a point of intersection S, to form an angle alpha. An entry point E, which is arranged with respect to the arrow axis 10 and marked as a point to be inserted between the two prosthetic elements 2; 3 in the intervertebral, The distance between is changed to a different angle α formed by the prosthetic axes L 1 and L 2 (FIGS. 3 and 4).

図3および4に示される2つの断面は、補綴軸LとLそれぞれに補綴要素2と3とが含まれる。補綴軸LとLの位置の修正によって生じる角度αの差異のために、断面S点は矢印軸10に沿って移動させられ、入り口の点Eは距離Aが増大するが変化せずに残る。特別な資料に与えられた評価に従い、図3に示されて椎体の端面の中央について背部に配置される断面S点を有する変形は、図4に示され端面の中央について前部に配置される断面S点を有する変形よりも比較して有利である。 The two cross sections shown in FIGS. 3 and 4 include prosthetic elements 2 and 3 on prosthetic axes L 1 and L 2, respectively. Due to the difference in the angle α caused by the correction of the position of the prosthetic axes L 1 and L 2, the point S of the cross section is moved along the arrow axis 10 and the point E of the entrance increases without increasing the distance A. Remain. In accordance with the evaluation given in the special material, the deformation shown in FIG. 3 and having a cross-section S-point placed in the back about the center of the end face of the vertebral body is shown in FIG. This is more advantageous than a deformation having a cross-sectional S point.

外科的方法についての記載
以下に椎間補綴1の植え込みを認容する外科的方法について図2を参照して記載される。
Description of Surgical Method A surgical method for accepting the implantation of the intervertebral prosthesis 1 will now be described with reference to FIG.

a)植込みの先行技術として、椎間板は補綴要素2,3の大きさによって要求されて準備される。全ての椎間板を除去する代わりに、2つの経路を明らかにすることのみが必要であり、椎間の補綴1の2つの同格表面4,5が椎体の被覆板に直接接触できるように前記2つの経路は十分大きい。この効果のために、椎間空間(椎間板)はそのような範囲でのみ除去され、2つの補綴要素の全体応用表面は、端板について接続される。一度、2つの補綴要素2,3が埋め込まれると、椎間板の残りは原位置に留まり、椎間の補綴が側面へ移動することを妨げる。   a) As a prior art of implantation, the intervertebral disc is prepared as required by the size of the prosthetic elements 2,3. Instead of removing all the intervertebral discs, it is only necessary to reveal the two pathways, said 2 so that the two equal surfaces 4, 5 of the intervertebral prosthesis 1 can directly contact the covering plate of the vertebral body. One path is big enough. Due to this effect, the intervertebral space (disc) is removed only in such a range, and the entire application surface of the two prosthetic elements is connected with respect to the endplate. Once the two prosthetic elements 2, 3 are implanted, the remainder of the intervertebral disc remains in place, preventing the intervertebral prosthesis from moving laterally.

b)次に椎間板内で2つの注入管の準備のために2つの補綴要素2,3の注入は2つの脊椎後側方固定術アクセス12,13を介して実行される。一組の補綴要素2,3の第一の埋め込みをすると直ぐに他の補綴要素2,3の埋め込が実行されることが好適である。2つの対応する明確な中央(帽子状構造9、凹部11)が縦軸L及びLの断面Sに配置すると直ちに、2つの補綴要素2,3は、帽子状構造9と凹部11とによって構成される関節14の手段により互いに結合する。椎間板部が2つの補綴要素2,3の側方に留まって帽子状構造9と凹部11とを結合させるために、椎間補綴1は補綴空間内にしっかりと留まる。回転中心は中央矢状平面に位置し、前方又は後方に変化しうるものであり、中央矢状平面は患者の体内を通過して前後に拡張され、前記体内の中央で交差する。 b) The injection of the two prosthetic elements 2,3 is then performed via the two posterior lateral fusion access 12,13 for the preparation of the two injection tubes in the disc. It is preferred that as soon as a first set of prosthetic elements 2, 3 is first embedded, the other prosthetic elements 2, 3 are embedded. As soon as the two corresponding clear centers (cap-like structure 9, recess 11) are arranged in the section S of the longitudinal axes L 1 and L 2 , the two prosthetic elements 2, 3 are separated by the cap-like structure 9 and the recess 11. They are connected to each other by means of the constructed joint 14. The intervertebral prosthesis 1 remains firmly in the prosthetic space because the intervertebral disc remains on the sides of the two prosthetic elements 2, 3 to join the cap-like structure 9 and the recess 11. The center of rotation is located in the central sagittal plane and can change forward or backward. The central sagittal plane passes through the patient's body and extends back and forth, intersecting the center of the body.

植込みのために2つの経椎間孔または椎間孔外へのアクセス12,13が使用され、脊椎外科において知られており、確立されている。一度、結合が効をなすと、2つの補綴要素2,3は、互いに関連して隣接する脊椎体の端板の勾配を認めるユニットを形成する。   Two transforaminal or extravertebral foramen access 12,13 are used for implantation and are known and established in spinal surgery. Once the connection is effective, the two prosthetic elements 2, 3 form a unit that recognizes the gradient of the endplates of adjacent vertebral bodies relative to each other.

椎間補綴1の後方植込み技術のために、脊柱の脊椎靱帯構造は無傷のままであり、脊柱を固定する機能も損傷していない。加えて、無傷の脊椎靱帯構造は、椎間補綴1の前方移動のリスクと脊柱領域の脊椎構造を危機にさらすリスクを削減する。外科的処置の同様の技術は、特により板材部と胸腰部領域でまた前方に適用される。アクセスが大動脈と大静脈によって遮られるので、解剖学的環境が厳密に前方への挿入を排除する。また、この場合には、前方の縦材の靱帯同様に繊維性の環状の脊椎構造は無傷に維持される。   Due to the posterior implantation technique of the intervertebral prosthesis 1, the spinal ligament structure of the spinal column remains intact and the function of fixing the spinal column is not damaged. In addition, the intact spinal ligament structure reduces the risk of anterior movement of the intervertebral prosthesis 1 and the risk of endangering the spinal structure in the spinal column region. Similar techniques for surgical procedures are also applied anteriorly, especially in the board and thoracolumbar regions. Since access is blocked by the aorta and vena cava, the anatomical environment strictly eliminates anterior insertion. Also, in this case, the fibrous annular spine structure is maintained intact, as is the ligament of the front longitudinal member.

本発明に係る椎間補綴の実施例の透視図である。1 is a perspective view of an embodiment of an intervertebral prosthesis according to the present invention. FIG. 図1に示す本発明に係る椎間補綴の実施例の平面図である。It is a top view of the Example of the intervertebral prosthesis based on this invention shown in FIG. 図1に示す本発明に係る椎間補綴の実施例の平面図であって、図2に類似するが異なる角度α、異なる距離Aにおける矢印軸10に沿って開示される断面Sの図である。FIG. 3 is a plan view of the embodiment of the intervertebral prosthesis according to the present invention shown in FIG. 1, and is a view of a cross-section S similar to FIG. .

Claims (14)

椎間補綴(1)、特に中央軸(6)を備える椎間板補綴であって、
A)中央軸(6)の横方向に配置される第一の隣接する脊椎体の端板と接触する第一の同格表面(4)と、中央軸(6)の横方向に配置される第一の内部表面(7)と、球形の凹部(11)とを有する第一の補綴要素(2)と、
B)中央軸(6)へ横方向に配置される第二の隣接する脊椎体の端板と接触する第二の同格表面(5)と、中央軸(6)の横にまた配置される第二の内部表面(8)と、前記凹部(11)に対応する帽子状構造(9)とを有する第二の補綴要素(3)とを備え、
C)第一および第二の補綴要素(2、3)は、凹部11を摺動自在に支える帽子構造(9)の手段によって関節のある手段と接続可能であり、
D)第一および第二の補綴要素(2、3)は、中央軸(6)の横に配置されてその幅の値がBでありその長さの値がHであり、さらに、前記第一および第二の補綴要素(2、3)はそれぞれの長さがHであって平行に延在する縦軸L1と縦軸L2を含み、
E)この長さHの値は幅Bの値より長く、前記第一および第二の補綴要素(2、3)は椎間空間内の位置にあり、2つの縦軸L1とL2とが交差してなす角度αはα>0度であり、
F)前記長さH対前記幅Bの比が3対1から5対1である椎間補綴(1)。
An intervertebral prosthesis (1), in particular an intervertebral disc prosthesis with a central axis (6),
A) a first equivalence surface (4) in contact with an end plate of a first adjacent vertebral body disposed laterally of the central axis (6), and a first disposed laterally of the central axis (6). A first prosthetic element (2) having one internal surface (7) and a spherical recess (11);
B) a second equivalence surface (5) in contact with the end plate of the second adjacent vertebral body arranged transversely to the central axis (6) and a second arranged next to the central axis (6). A second prosthetic element (3) having a second inner surface (8) and a cap-like structure (9) corresponding to the recess (11),
C) The first and second prosthetic elements (2, 3) can be connected to articulated means by means of a cap structure (9) which slidably supports the recess 11;
D) The first and second prosthetic elements (2, 3) are arranged beside the central axis (6), have a width value of B and a length value of H, The first and second prosthetic elements (2, 3) each have a length H and a longitudinal axis L1 and a longitudinal axis L2 extending in parallel,
E) The length H is longer than the width B, and the first and second prosthetic elements (2, 3) are located in the intervertebral space and the two longitudinal axes L1 and L2 intersect. The angle α is α> 0 degrees,
F) An intervertebral prosthesis (1) in which the ratio of the length H to the width B is 3: 1 to 5: 1.
第一および第二の補綴要素(2、3)のうちの一つおよび帽子状構造(9)は一部品から構成される請求項1に記載の椎間補綴(1)。 One and hat-like structure of the first and second prosthetic components (2, 3) (9) is intervertebral prosthesis according to configured claim 1 from a component (1). 前記椎間補綴(1)は、第一および第二の補綴要素(3)の1つと脱着可能な第三の部品からなる帽子状構造(9)の少なくとも3つの部品から構成される請求項1に記載の椎間補綴(1)。The intervertebral prosthesis (1), the first and second prosthetic components (3) of one claim comprised of at least three parts of the hat-like structure made of detachable third part (9) 1 the intervertebral prosthesis according to (1). 前記椎間補綴(1)は、少なくとも3つの部品から構成されて関節殻を含み、この殻は第三の部分として第一および第二の補綴要素(2)に脱着可能な凹部を含む請求項1乃至3のいずれか一項に記載の椎間補綴(1)。The intervertebral prosthesis (1) is composed of at least three parts and includes a joint shell, the shell including as a third part a recess detachable from the first and second prosthetic elements (2). the intervertebral prosthesis according to any one of 1 to 3 (1). 帽子状構造(9)と関節殻は金属とプラスティックの組み合わさった物質から構成される請求項に記載の椎間補綴(1)。The intervertebral prosthesis (1) according to claim 4 , wherein the cap-like structure (9) and the joint shell are made of a combined material of metal and plastic. 帽子状構造(9)と関節殻は複数のセラミックの組み合わさった物質から構成される請求項に記載の椎間補綴(1)。The intervertebral prosthesis (1) according to claim 4 , wherein the cap-like structure (9) and the joint shell are composed of a combination of a plurality of ceramic materials. 帽子状構造(9)と凹部(11)の表面は炭化チタンまたはアモルファス炭素(ADLC)によって被覆されている請求項1乃至6のいずれか一項に記載の椎間補綴(1)。The intervertebral prosthesis (1) according to any one of claims 1 to 6, wherein the cap-like structure (9) and the surface of the recess (11) are covered with titanium carbide or amorphous carbon (ADLC). 帽子状構造(9)は少なくとも形状記憶合金から構成される請求項1乃至7のいずれか一項に記載の椎間補綴(1)。Hat like structure (9) is intervertebral prosthesis according to any one of constituted claims 1 to 7 at least the shape memory alloy (1). 少なくとも帽子状構造(9)が膨張能力を有する物質からなる請求項1乃至7のいずれか一項に記載の椎間補綴(1)。The intervertebral prosthesis (1) according to any one of claims 1 to 7, wherein at least the cap-like structure (9) is made of a substance having an expansion ability. 少なくとも帽子状構造(9)が流動性および熱硬化性を有する物質からなる請求項1乃至7のいずれか一項に記載の椎間補綴(1)。The intervertebral prosthesis (1) according to any one of claims 1 to 7, wherein at least the cap-like structure (9) is made of a material having fluidity and thermosetting properties. 少なくとも帽子状構造(9)は、モノマー、コモノマー、ホモポリマー、オリゴマー、または、流動性および熱硬化性を有する物質を含む混成物質からなる請求項10に記載の椎間補綴(1)。The intervertebral prosthesis (1) according to claim 10 , wherein at least the cap-like structure (9) is composed of a monomer, a comonomer, a homopolymer, an oligomer, or a hybrid material comprising a material having fluidity and thermosetting properties. 熱硬化性および流動性物質は以下のグループ
a)ポリエチレングリコール、好適にはポリエチレングリコール(ジ)−アクリレート
b)n−ビニルピロリドン
c)ビニル、好適にはビニルアルコール
d)スチレン
から選択される請求項11に記載の椎間補綴(1)。
The thermosetting and flowable material is selected from the following group a) polyethylene glycol, preferably polyethylene glycol (di) -acrylate b) n-vinyl pyrrolidone c) vinyl, preferably vinyl alcohol d) styrene. 11. The intervertebral prosthesis (1) according to 11.
前記第一の補綴要素(2)は、少なくとも2つの第一の補綴要素(2)の第一のキットから選択される請求項1乃至12のいずれか一項に記載の椎間補綴(1)。It said first prosthetic component (2) is intervertebral prosthesis according to any one of claims 1 to 12 selected from the first kit of at least two first prosthetic component (2) (1) . 前記第二の補綴要素(2)は、少なくとも2つの第二の補綴要素(2)の第二のキットから選択される請求項1乃至13のいずれか一項に記載の椎間補綴(1)。It said second prosthetic component (2) is intervertebral prosthesis according to any one of claims 1 to 13 selected from the second kit of at least two second prosthetic components (2) (1) .
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